MAUDE Adverse Event Report: TRACOE MEDICAL GMBH TRACOE SILCOSOFT TRACHEOSTOMY CANNULA; TRACOE SILCOSOFT TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE,

Model Number	REF 372-5.0
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of this incidents needs further details from the user/customer.These were addressed on 12.06.2025: how long was the tracoe silcosoft cannula used? not answered.When was the leak in the cuff discovered? not answered.How often was the cannula cleaned / disinfected? not answered.Is the cannula available for examination at tracoe? not answered.What information is available about the patient's condition? not answered.Has this defect occurred previously at the customer's site? not answered.No further details of the incident have been provided by the user.The tube was returned to tracoe and examined on 11.06.2025: the examination of the affected tube showed a small hole in the filling line close to the neck plate.A second tube showed no leakage.Due to the discoloration of the cannula, it can be assumed that it has been in use for some time.Accidental punctures and cuts by sharp instruments may therefore have led to the punctiform damage of the filling tube.This damage lead to the leakage of the cuff system.Other causes from production or material are more likely to be ruled out, as the cannula 1.Is 100% tested for cuff leakage in production and 2.) this cannula has already been used for a certain period of time.
Event or Problem Description
1) what went wrong with the device: it was reported that the cuff of a tracoe silcosoft cannula deflated during use so that water escapes from the cuff system.It was not reported if the cuff was tested before use as it is described in the ifu, how long the cannula was used and how many times the cannula had been cleaned / sterilized.2) description of health effects: no health effect was reported.

• Brand Name: TRACOE SILCOSOFT TRACHEOSTOMY CANNULA
• Common Device Name: TRACOE SILCOSOFT TRACHEOSTOMY CANNULA WITH CUFF AND SUCTION LINE,
• Manufacturer (Section D): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer (Section G): TRACOE MEDICAL GMBH; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• Manufacturer Contact: margarete halle ; reichelsheimer str. 1/3; nieder-olm, 55268 ; GM 55268
• MDR Report Key: 22334343
• Report Number: 8010485-2025-00029
• Device Sequence Number: 9191028
• Product Code: JOH
• UDI-Device Identifier: 04035324028443
• UDI-Public: 4035324028443
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: 505
• Remedial Action: Other,Replace
• Type of Report: Initial
• Report Date (Section B): 06/26/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: REF 372-5.0
• Device Catalogue Number: REF 372-5.0
• Device Lot Number: 1100042306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male